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BACKGROUND. Musculoskeletal pain is a common condition, raising the concern these patients may transition to chronic opioid use. However, the incidence of and risk factors for chronic opioid use among patients with new musculoskeletal pain are not fully understood. OBJECTIVE. To characterize the incidence and risk factors of chronic opioid use among opioid-naive patients with newly diagnosed musculoskeletal pain in the knee, neck, low back, and/or shoulder. METHODS AND FINDINGS. The IBM® Marketscan® database provide health care utilization data for patients receiving private insurance through a participating employer or government organization. Compared to the general United States (US) population, the Marketscan® population is slightly more female and from the southern US, and less likely to come from the western US.(1) Using this data, we identified 518,195 privately insured, cancer-free, and opioid-naïve (no filled opioid prescriptions in the year prior to diagnosis) adults ages 18–64 diagnosed with non-trauma related musculoskeletal pain between January 1, 2008 and December 31, 2014 and who remained continuously enrolled for the year before and after the initial diagnosis. Since musculoskeletal pain can have varying levels of severity, we restricted our analysis to patients with pain severe enough to result in a second outpatient visit or emergency room visit for musculoskeletal pain within 30 days of the initial diagnosis date.(2) We excluded 6,036 patients with missing opioid data and 100,138 patients with conditions that could be confused for musculoskeletal low back pain (nepholithiasis, urinary tract infection, osteomyelitis, cholecystitis, osteoporosis, cauda equina syndrome, and osseous defect), resulting in a final sample of 412,021 patients.

BACKGROUND: Self-report information about pain and pain beliefs are often collected during initial consultation for musculoskeletal pain. These data may provide utility beyond the initial encounter, helping provide further insight into prognosis and long-term interactions of the patient with the health system. OBJECTIVE: The aim of this study was to determine if pain catastrophizing and pain-related body symptoms can predict future health care utilization. METHODS: This was a longitudinal cohort study. Baseline data were collected after receiving initial care for a musculoskeletal disorder in a multidisciplinary clinic within a large military hospital. Subjects completed the Pain Catastrophizing Scale, a region-specific disability measure, numeric pain rating scale and a body symptom diagram. Health care utilization data for 1 year prior and after the visit were extracted from the Military Health System Data Repository. Multivariable regression models appropriate for skewed and count data were developed to predict (i) musculoskeletal-specific medical visits, (ii) 12-month opioid use, (iii) musculoskeletal-specific medical costs and (iv) total medical costs. We investigated whether a pain catastrophizing × body symptom diagram interaction improved prediction, and developed separate models for opioid-naïve individuals and those with a history of opioid use in an exploratory analysis. RESULTS: Pain catastrophizing but not body symptom diagram was a significant predictor of musculoskeletal visits, musculoskeletal costs and total medical costs. Exploratory analyses suggest these relationships are most robust for patients with a history of opioid use. CONCLUSIONS: Pain catastrophizing can identify risk of high health care utilization and costs, even after controlling for common clinical variables. Addressing pain catastrophizing in the primary care setting may help to mitigate future health care utilization and costs, while improving clinical outcomes. These results provide direction for future validation studies in ...

This study determined the predictive capabilities of pain intensity and disability on health care utilization (number of condition-specific health care visits, incident and chronic opioid use) and costs (total condition-specific and overall medical costs) in the year following an initial evaluation for musculoskeletal pain. We explored pain catastrophizing and spatial distribution of symptoms (i.e., body diagram symptom score) as mediators of these relationships. Two hundred eighty-three military service members receiving initial care for a musculoskeletal injury completed a region-specific disability measure, numeric pain rating scale, Pain Catastrophizing Scale (PCS) and body pain diagram. Pain intensity predicted all outcomes, while disability predicted incident opioid use only. No mediation effects were observed for either opioid use outcome, while pain catastrophizing partially mediated the relationship between pain intensity and number of health care visits. Pain catastrophizing and spatial distribution of symptoms fully mediated the relationship between pain intensity and both cost outcomes. The mediation effects of pain catastrophizing and spatial distribution of symptoms are outcome-specific, and more consistently observed for cost outcomes. Higher pain intensity may drive more condition-specific health care utilization and use of opioids, while higher catastrophizing and larger spatial distribution of symptoms may drive higher costs for services received. PERSPECTIVE: This article examines underlying characteristics that help explain relationships between pain intensity and disability, and the outcomes of health care utilization and costs. Health care systems can use these findings to refine value-based prediction models by considering factors that differentially influence outcomes for health care use and cost of services.

BACKGROUND: The opioid misuse epidemic focused national attention on reducing opioid overprescribing. The purpose of this study is to describe the relationship of time and state-level interventions and opioid filling surrounding total hip arthroplasty (THA) in the United States. METHODS: A national database with diverse insurance constituents was queried for first-prescription and cumulative perioperative opioid filling volumes and rates in oxycodone 5-mg equivalents (OE's) in 487,942 patients undergoing primary THA from 30-days pre-operative to 90-days post-operative. Descriptive statistics evaluated pre-legislative and post-legislative opioid filling by state, legislative type, and surgery year. RESULTS: At the national level, initial opioid filling volumes have remained largely unchanged (56.2 OE's in 2010 to 51.7 OE's in 2018). Meanwhile, cumulative opioid filling volumes (151.9 OE's in 2010 to 111.7 OE's in 2018) have decreased considerably. Rates of initial opioid prescriptions exceeding 90 OE's were similar in 2010 (6.4%) and 2018 (5.6%). States with legislation targeting duration and volume of opioid prescriptions saw the largest decreases in opioid prescription filling. That is, 75% of states with opioid legislation had large (> 10 oxycodone 5-mg equivalents) decreases in cumulative 90-day opioid filling compared to only 20% of states without opioid legislation having large decreases in cumulative 90-day opioid filling. CONCLUSIONS: This descriptive study demonstrates decreases in perioperative opioid filling for THA. Although this study was descriptive in nature, states enacting opioid-limiting legislation had larger decreases. Although causal relationships could not be inferred from this analysis, the results suggest that states without legislation could improve prescriber compliance with national goals of decreased opioid overprescribing by enacting opioid-limiting legislation. LEVEL OF EVIDENCE: Level III, retrospective prognostic cohort study. SUPPLEMENTARY INFORMATION: The online version ...

openAccessArticle: False ; Page Range: S27-S27 ; doi:10.1016/j.spinee.2012.08.093 ; Harvest Date: 2016-01-12 15:10:49 ; issueName: Proceedings of the 27th Annual Meeting of the North American Spine Society ; cover date: 2012-09-01 ; pubType: Outstanding Paper: Value Runner-Up (Not Presented)

Abstract Background Effective strategies for the primary prevention of low back pain (LBP) remain elusive with few large-scale clinical trials investigating exercise and education approaches. The purpose of this trial was to determine whether core stabilization alone or in combination with psychosocial education prevented incidence of low back pain in comparison to traditional lumbar exercise. Methods The Prevention of Low Back Pain in the Military study was a cluster randomized clinical study with four intervention arms and a two-year follow-up. Participants were recruited from a military training setting from 2007 to 2008. Soldiers in 20 consecutive companies were considered for eligibility (n = 7,616). Of those, 1,741 were ineligible and 1,550 were eligible but refused participation. For the 4,325 Soldiers enrolled with no previous history of LBP average age was 22.0 years (SD = 4.2) and there were 3,082 males (71.3%). Companies were randomly assigned to receive traditional lumbar exercise, traditional lumbar exercise with psychosocial education, core stabilization exercise, or core stabilization with psychosocial education, The psychosocial education session occurred during one session and the exercise programs were done daily for 5 minutes over 12 weeks. The primary outcome for this trial was incidence of low back pain resulting in the seeking of health care. Results There were no adverse events reported. Evaluable patient analysis (4,147/4,325 provided data) indicated no differences in low back incidence resulting in the seeking of health care between those receiving the traditional exercise and core stabilization exercise programs. However, brief psychosocial education prevented low back pain episodes regardless of the assigned exercise approach, resulting in a 3.3% (95% CI: 1.1 to 5.5%) decrease over two years (numbers needed to treat (NNT) = 30.3, 95% CI = 18.2 to 90.9). Conclusions Core stabilization has been advocated as preventative, but offered no such benefit when compared to traditional lumbar exercise in this trial. Instead, a brief psychosocial education program that reduced fear and threat of low back pain decreased incidence of low back pain resulting in the seeking of health care. Since this trial was conducted in a military setting, future studies are necessary to determine if these findings can be translated into civilian populations. Trial Registration NCT00373009 at ClinicalTrials.gov - http://clinicaltrials.gov/

The general population has a pessimistic view of low back pain (LBP), and evidence-based information has been used to positively influence LBP beliefs in previously reported mass media studies. However, there is a lack of randomized trials investigating whether LBP beliefs can be modified in primary prevention settings. This cluster randomized clinical trial investigated the effect of an evidence-based psychosocial educational program (PSEP) on LBP beliefs for soldiers completing military training. A military setting was selected for this clinical trial, because LBP is a common cause of soldier disability. Companies of soldiers (n = 3,792) were recruited, and cluster randomized to receive a PSEP or no education (control group, CG). The PSEP consisted of an interactive seminar, and soldiers were issued the Back Book for reference material. The primary outcome measure was the back beliefs questionnaire (BBQ), which assesses inevitable consequences of and ability to cope with LBP. The BBQ was administered before randomization and 12 weeks later. A linear mixed model was fitted for the BBQ at the 12-week follow-up, and a generalized linear mixed model was fitted for the dichotomous outcomes on BBQ change of greater than two points. Sensitivity analyses were performed to account for drop out. BBQ scores (potential range: 9–45) improved significantly from baseline of 25.6 ± 5.7 (mean ± SD) to 26.9 ± 6.2 for those receiving the PSEP, while there was a significant decline from 26.1 ± 5.7 to 25.6 ± 6.0 for those in the CG. The adjusted mean BBQ score at follow-up for those receiving the PSEP was 1.49 points higher than those in the CG (P < 0.0001). The adjusted odds ratio of BBQ improvement of greater than two points for those receiving the PSEP was 1.51 (95% CI = 1.22–1.86) times that of those in the CG. BBQ improvement was also mildly associated with race and college education. Sensitivity analyses suggested minimal influence of drop out. In conclusion, soldiers that received the PSEP had an improvement in their ...

BACKGROUND: The Pain Management Collaboratory (PMC) is a multi-site network of pragmatic clinical trials (PCTs) focused on nonpharmacological approaches to pain management, conducted in health care systems of the US Department of Defense (DoD) and Department of Veterans Affairs (VA) and co-funded by the National Institutes of Health (NIH). Concerns about potential research-site overlap prompted the PMC investigator community to consider strategies to avert this problem that could negatively affect recruitment and contaminate interventions and thus pose a threat to trial integrity. METHODS: We developed a two-step strategy to identify and remediate research-site overlap by obtaining detailed recruitment plans across all PMC PCTs that addressed eligibility criteria, recruitment methods, trial settings, and timeframes. The first, information-gathering phase consisted of a 2-month period for data collection from PIs, stakeholders, and ClinicalTrials.gov. The second, remediation phase consisted of a series of moderated conference calls over a 1-month time period to develop plans to address overlap. Remediation efforts focused on exclusion criteria and recruitment strategies, and they involved collaboration with sponsors and stakeholder groups such as the Military Treatment Facility Engagement Committee (MTFEC). The MTFEC is comprised of collaborating DoD and university-affiliated PIs, clinicians, and educators devoted to facilitating successful pragmatic trials in DoD settings. RESULTS: Of 61 recruitment sites for the 11 PMC PCTs, 17 (28%) overlapped. Four PCTs had five overlapping Military Treatment Facilities (MTFs), and eight PCTs had 12 overlapping VA Medical Centers (VAMCs). We developed three general strategies to avoid research-site overlap: (i) modify exclusion criteria, (ii) coordinate recruitment efforts, and/or (iii) replace or avoid any overlapping sites. Potential overlap from competing studies outside of the PMC was apparent at 26 sites, but we were not able to confirm them as true conflicts. ...

Abstract Background Achieving adequate follow-up in clinical trials is essential to establish the validity of the findings. Achieving adequate response rates reduces bias and increases probability that the findings can be generalized to the population of interest. Therefore, the purpose of this study was to determine the influence of attention, demographic, psychological, and health status factors on web-based response rates in the ongoing Prevention of Low Back Pain in the Military (POLM) trial. Methods Twenty companies of Soldiers (n = 4,325) were cluster randomized to complete a traditional exercise program including sit-ups (TEP) with or without a psychosocial educational program (PSEP) or a core stabilization exercise program (CSEP) with or without PSEP. A subgroup of Soldiers (n = 371) was randomized to receive an additional physical and ultrasound imaging (USI) examination of key trunk musculature. As part of the surveillance program, all Soldiers were encouraged to complete monthly surveys via email during the first year. Descriptive statistics of the predictor variables were obtained and compared between responders and non-responders using two sample t-tests or chi-square test, as appropriate. Generalized linear mixed models were subsequently fitted for the dichotomous outcomes to estimate the effects of the predictor variables. The significance level was set at .05 a priori. Results The overall response rate was 18.9% (811 subjects) for the first year. Responders were more likely to be older, Caucasian, have higher levels of education and income, reservist military status, non smoker, lower BMI, and have received individualized attention via the physical/USI examination (p < .05). Age, race/ethnicity, education, military status, smoking history, BMI, and whether a Soldier received the physical/USI examination remained statistically significant (p < .05) when considered in a full multivariate model. Conclusion The overall web based response rate during the first year of the POLM trial was consistent with studies that used similar methodology, but lower when compared to rates expected for standard clinical trials. One year response rate was significantly associated with demographic characteristics, health status, and individualized attention via additional testing. These data may assist for planning of future trials that use web based response systems. Trial Registration This study has been registered at reports at http://clinicaltrials.gov ( NCT00373009 ).